EUCTR2013-005558-31-GB进行中（未招募）1 期
International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM study I10E-1302 - PRISM 2
FB BIOTECHNOLOGIES0 个研究点目标入组 30 人开始时间: 2014年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male or female patient aged 18 years or more.
- •2. Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease =1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
- •3. Covered by national healthcare insurance system as required
- •by local regulations.
- •4. Written informed consent obtained prior to any study-related
- •procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Based on follow-up and results of analyses performed in PRISM
- •I10E-1302 study, a patient may be eligible in PRISM 2 I10E-1306
- •study if none of the following criteria is met:
- •1. History of severe allergic reaction or serious adverse reaction to
- •2. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
- •3. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
- •4. History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
- •5. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
- •6. History of personal or familial congenital thrombophilia or acquired thrombophilia.
- •7. Factors contributing to venous stasis such as long-term bed confinement.
- •8. Body mass index (BMI) =40 kg/m².
- •9. Protein-losing enteropathy characterised by total serum protein levels <60
- •g/L and serum albumin levels <30 g/L
- •10. History of kidney transplantation, nephrotic syndrome (defined
- •as proteinuria >3.5 g per 24 hours accompanied by
- •hypoalbuminemia and edema), or any acute or chronic kidney disease that in the opinion of the investigator and/or nephrologist would preclude the use of I10E and/or interfere with the assessment of the safety and efficacy of I10E.
- •Chronic kidney disease (CKD) for more than 3 months as documented by at least one of the following:
- •glomerular filtration rate (GFR) <60 mL/min/1.73m2 measured according to the Modified Diet in Renal Disease (MDRD) formula
- •urine protein reagent strip: =2 crosses
- •urine protein reagent strip: one cross with one of the following:
- •or albumin excretion rate (AER) >300 mg/24 hours
- •or protein excretion rate (PER) >500 mg/24 hours (24h-urine collection)
- •or albumin to creatinine ratio (ACR) >30 mg/mmol
- •or protein to creatinine ratio (PCR) >50 mg/mmol (spot urine sample).
- •11. Serum levels of Alanine aminotransferase (ALT) or Aspartate
- •aminotransferase (AST) >2 times upper limit of normal range (ULN).
- •12. Any other ongoing disease that may cause chronic peripheral
- •neuropathy, such as toxin exposure, dietary deficiency,
- •uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus
- •erythematosus or other connective tissue diseases, infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
- •13. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception. Effective contraceptives are injectable, patch or combined oestro-progestative or progestative contraceptives, Copper T or levonorgest releasing intra-uterine devices, depot intramus
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